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Allergan Glaucoma Gel Stent Filing Accepted for FDA Review

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Allergan plc announced that FDA has accepted its 510(k) Premarket Notification Application for the XEN Glaucoma Treatment System, comprising XEN45 gel stent and XEN injector, for review. XEN45 gel stent is a minimally invasive, implantable, cross- linked gelatin shunt used to reduce intraocular pressure associated with refractory glaucoma.

We note that, XEN45 enjoys the CE mark in the EU and is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma who have failed previous medical treatments.

According to information provided by the company in its press release, 60.5 million people were living with glaucoma in 2010. Moreover, the company expects the number of people suffering from glaucoma to increase to nearly 80 million by 2020 due to the growing aged population.

With the Allergan, Inc. acquisition, Allergan, which was previously known for its strong presence in the generics market, finds itself in the company of the top 10 pharma companies across the world based on sales. Allergan has been actively pursuing acquisitions to expand its presence in the branded market. The sale of its generics business to Teva will allow Allergan to focus on its branded segment.

Allergan currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Bristol-Myers Squibb Company (BMY - Free Report) and Amphastar Pharmaceuticals, Inc. (AMPH - Free Report) – both sporting a Zacks Rank #1 (Strong Buy) and Teligent, Inc. (TLGT - Free Report) carrying a Zacks Rank #2 (Buy).

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